FDA Intros New Programs to Combat the Opioid Epidemic

The Food and Drug Administration (FDA) has introduced several new programs
and advices recently, aimed squarely at combating the nation's deadly
opioid epidemic.

Among the programs and advices are:

Prescribing guidelines In late August, FDA Commissioner Scott Gottlieb, M.D., announced "new
steps to advance the development of evidence-based, indication-specific
guidelines to help guide appropriate prescribing of opioid analgesics."

Veterinarian advice The FDA also announced "important information for veterinarians to
ensure they have additional context regarding the potential for people
to misuse the products that they are prescribing to their animal patients."

Innovative MAT drugs Earlier in the month, the agency released "new scientific recommendations
aimed at encouraging more widespread innovation and development of novel
medication-assisted treatment (MAT) drugs for the treatment of opioid
use disorder (OUD)."

Patient perspectives Early in July, the agency kicked off this round of opioid epidemic projects
with a public meeting on "patient-focused drug development for chronic
pain... to hear patient perspectives on chronic pain, views on treatment
approaches, and challenges or barriers to accessing treatments for chronic
pain."

These and other programs have evolved from the FDA's Opioid Policy
Steering Committee (OPSC). Formed last year with the agency's most
senior staff, it was tasked with finding new approaches to combat the epidemic.

"One overarching goal of the committee," Gottlieb said recently,
"was to develop new policy solutions to reduce overall exposure to
opioids, prevent new addictions, and support the development and use of
better FDA-approved medications to treat those with opioid use disorder."

Among the actions recommended by the OPSC were to solicit more input from
the public. In September, 2017, the FDA asked for ideas on how the agency
could be better used to address the crisis. This led to a public meeting
in early 2018 to gather specific input on the FDA's role in creating
more appropriate opioid prescribing guidelines.

Prescribing guidelines

Many people who become addicted to opioids are first exposed to them through
a prescription.

"The fact remains that there are still too many prescriptions being
written for opioids," Gottlieb said in a statement. "And too
many prescriptions are written for longer durations of use than are appropriate
for the medical need being addressed."

To that end, the agency has asked the National Academies of Sciences, Engineering,
and Medicine (NASEM) to help develop "evidence-based guidelines for
appropriate opioid analgesic prescribing for acute pain resulting from
specific conditions or procedures."

NASEM will identify and prioritize procedures and conditions associated
with acute pain for which opioids are commonly prescribed. It will also
study all existing guidelines, and outline new research that might be needed.

Veterinarian advice

Although it's not a major source of diversion, people continue to swipe
their pet's opioids, and frequently enough to draw the attention of the FDA.

To this end, the agency has released a detailed new guideline for veterinarians,
The Opioid Epidemic: What Veterinarians Need to Know. The guideline contains
"important information for veterinarians to ensure they have additional
context regarding the potential for people to misuse the products that
they are prescribing to their animal patients," Gottlieb said.

More innovative MAT drugs

The agency has released a new draft guidance for drug companies to use
to measure and demonstrate the effectiveness and benefits of new MAT drugs
they might develop.

The agency points out that it is only helpful guidelines, not policy, and
represents "the current thinking of the agency on this topic."

Patient perspectives

The FDA has said that chronic pain affects 100 million US adults, impacting
livelihoods and well-being while contributing to morbidity and disability
nationwide. With an estimated economic impact close to $600 billion a
year, chronic pain continues to be a major focal point for more effective
and safer opioid prescription policies.